Food Safety Rules Proposed By The FDA

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Nutrition / Diet;  Public Health
Article Date: 06 Jan 2013 - 2:00 PST


Two new food safety rules to help prevent foodborne illnesses have been proposed by the US FDA (Food and Drug Administration).

The FDA says that its proposals will be available for public comment during the coming three months. It claims that its new proposals on safety rules will put into practice the aims of the bipartisan FDA Food Safety Modernization Act (FSMA).

Americans are encouraged to review the proposals, as well as the comments that will come.

According to the Agency, its proposed rules build on important steps taken during the current Administration, including:

• The first egg safety rule protecting consumers from Salmonella
• More rigorous testing of beef for E. coli
• Voluntary guidelines for food safety - which the Agency claims are well followed

According to the FDA:

"The rules follow extensive outreach by the FDA to the produce industry, the consumer community, other government agencies and the international community. Since January 2011, FDA staff have toured farms and facilities nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community."

Health and Human Services Secretary Kathleen Sebelius calls the FDA FSMA a "sensible law" which turns the focus of food safety from a reactive to a preventive one. "With the support of industry, consumer groups, and the bipartisan leadership in Congress, we are establishing a science-based, flexible system to better prevent foodborne illness and protect American families."

The "Substantial" Burden of Foodborne Illness in the USA

According to the FDA, the burden of foodborne illness in the USA is 'substantial'.

• Each year, one sixth of the country's population suffers from a foodborne illness.
• Nearly 130,000 people are hospitalized each year from foodborne illnesses
• Foodborne illnesses cause 3,000 deaths each year

Not only will preventing foodborne illnesses save people from becoming seriously ill and dying, it will also reduce medical costs and avoid the disruptions of the food system and the high costs that outbreaks and recalls incur.

The FSMA rules form part of an integrated effort at reforming national food safety, and have a strong focus on prevention. It is important that the American public has access to safe food that is produced both at home and abroad. Rules regarding the importation of foods will be published shortly, the FDA added.

The first proposed rule

Makers of food that is sold in the USA should develop a formal plan to make sure their food products do not cause foodborne illnesses. This is includes foods produced at foreign or domestic based facilities.

The rule will also require food makers to have plans laid out to correct any problems as they occur.

The American public is invited to comment on this proposal.

The Agency wrote in an online communiqué "The FDA is proposing that many food manufacturers be in compliance with the new preventive controls rules one year after the final rules are published in the Federal Register but small and very small businesses would be given additional time."

The second proposed rule

Safety standards for the production and harvesting of farmed products. The rule would not be voluntary, but enforceable. The FDA proposes science-and risk-based standards for the proper harvesting and production of vegetables and fruits.

The Agency is also inviting the public to comment on this proposed rule.

Larger farms should adhere to most of the produce safety requirements within 26 months of the final rule when it is published in the Federal Register. Smaller farms would be given longer to comply. Requirements related to water quality would be implemented over the longer-term.

FDA Commissioner Margaret A. Hamburg, M.D., said:

"The FDA knows that food safety, from farm to fork, requires partnership with industry, consumers, local, state and tribal governments, and our international trading partners. Our proposed rules reflect the input we have received from these stakeholders and we look forward to working with the public as they review the proposed rules."

Extensive research and consultations were done before the FDA issued the two proposed rules, including local meetings in 14 states, making hundreds of presentations, and five federal public meetings. Farms and various types of facilities were also visited and consulted.

Michael R. Taylor, the FDA's deputy commissioner for foods and veterinary medicine, said "We know one-size-fits-all rules won't work. We've worked to develop proposed regulations that can be both effective and practical across today's diverse food system."

Importers will have to adhere to some additional rules which will soon be presented, the FDA added. The Agency stressed that improving oversight of imported food is a vital part of FSMA's goal. Nearly 15% of all food consumed in the USA comes in from abroad - many high-risk products are imported.

New rules will also be proposed regarding animal food facilities. The FDA says the rules will be similar to the preventive ones that currently exist for human food.

For more information:

• Federal Register Notice for the Proposed Rule "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food"
• Federal Register Notice for the Proposed Rule "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption"

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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